NEW YORK (Reuters Health) – A new 14-day adhesive monitoring patch detects more arrhythmias than 24-hour Holter monitoring does, according to a new paper.
“For screening arrhythmias this is a far more sensitive and easy to use device,” Dr. Eric J. Topol from Scripps Translational Science Institute, La Jolla, California told Reuters Health. “The Holter, which has been around since 1949, will likely become obsolete in the near term due to modern, innovative digital technology.”
The Zio Patch is an FDA-cleared, single lead, lightweight, 14-day ambulatory ECG adhesive patch monitor that has no external leads or wires. “The ease of use for the patient–patch sent in the mail and then returned via mail–is far more convenient than the Holter that requires two visits to a clinic/hospital,” Dr. Topol said.
Dr. Topol and colleagues evaluated the diagnostic utility of the patch for up to 14 days as compared with standard 24-hour Holter monitoring in 146 patients (median age, 64 years) who wore both systems at the same time (the Holter for a median 1.0 day and the patch for a median 11.1 days).
More than 90% of patients found the adhesive monitoring patch comfortable to wear, compared with only half for the Holter monitor (93.7% vs 51.7%). When asked which monitor they would prefer to wear, 81% chose the adhesive patch monitor.
Of 102 physicians surveyed, 92 (90%) felt a definitive diagnosis was achieved with data from the adhesive patch monitor, compared with 65 (64%) with data from the Holter monitor, the authors reported online October 15th in The American Journal of Medicine.
The Holter monitor detected 61 arrhythmia events, while the adhesive patch monitor detected 96, including 36 events that were undetected by the Holter monitor primarily as a function of prolonged monitoring.
Even after excluding less clinically meaningful supraventricular tachycardias, the adhesive patch monitor detected 14 clinically significant arrhythmia events that were missed by the Holter monitor.
When only the 24 hours of simultaneous wear were compared, the Holter detected 11 arrhythmia events undetected by the adhesive patch monitor, and the patch detected 2 arrhythmia events undetected by the Holter monitor. Of the 11 events missed by the patch in those first 24 hours, 10 were eventually detected beyond 24 hours.
Only three events detected by the Holter monitor and missed by the patch over the initial 24 hours of monitoring (but subsequently detected) were felt to be more clinically significant.
“I think getting 10-14 days of heart rhythm monitoring will always be favored over 24 hours,” Dr. Topol said.
“The Holter can record multiple leads which can be an advantage in unusual arrhythmias,” he added. “Currently the adhesive patch only records one lead, but my understanding is that will be expanded to multiple.”
Dr. Peter Zimetbaum from Harvard Medical School in Boston told Reuters Health he almost never uses Holter monitors anymore. “I strongly favor the patch – the real issue is reimbursement. This remains an unsettled issue for the patch and in some cases makes it difficult to use clinically.”
“For most patients real time data is not required and the ease of use of the patch makes this is preferred option,” Dr. Zimetbaum said. “Eventually we will likely have a patch device with real time data monitoring capability – question is will it be inexpensive enough to prove cost effective as a monitoring tool?”
In the opinion of Dr. Suave Lobodzinski from David Geffen School of Medicine at UCLA, “The patch has some well defined advantages over traditional Holter monitors” that include better patient acceptance and longer monitoring.
“However,” Dr. Lobodzinski added in email to Reuters Health, “it also has some disadvantages.”
The problems, Dr. Lobodzinski said, are: “1) the diagnostic information from a single channel patch monitor is limited and placement dependent…, 2) aggressive adhesives that allow the patch to stay on the skin for prolonged periods of time may cause significant dermatitis, 3) due to huge amount of collected data, the analysis has to take place in a dedicated, proprietary data processing center, hence the physician has access only to the final report, 4) the patch monitor is considered an experimental device by the insurers and there is no reimbursement for its use.”
But, Dr. Lobodzinski added, “The patch technology is here to stay and we may expect the emergence of multi-sensor patches in the near future that would be capable of monitoring respiration, temperature, oxygen saturation and 3-D motion in addition to ECG. Furthermore, these future devices may have real-time telemetry capabilities thus allowing for timely alarms and interventions.”
And as Dr. Emanuela T. Locati from Azienda Ospedaliera Niguarda Ca’Granda, Milan, Italy told Reuters Health by email, “New external and noninvasive techniques such as patch recorders are very useful to detect paroxysmal arrhythmias that would have gone undiagnosed with the classic Holter monitoring.”
“Furthermore,” she said, “patch recorders are a valid alternative to implantable loop recorders, which are very expensive and minimally invasive, and should be reserved for those cases still undiagnosed after 15-30 days of external loop recorders.” [
iRhythm Technologies Inc., San Francisco, California, which manufactures the Zio Patch System, provided funding for this study. None of the authors reported any conflict of interest.
Am J Med 2013.